| CTRI Number |
CTRI/2024/06/068357 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
A Descriptive Study On Siddha Diagnostic Methodology And Diet Regimen For Vadha Karsanam |
|
Scientific Title of Study
|
A Descriptive Study on Siddha Diagnostic Methodology Especially Neerkuri,Neikuri And Line of Treatment,Dietary Regimen For VADHA KARSANAM |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr E P POONGODI |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college and hospital, Palayamkotta |
| Address |
Department of Noi Naadal, Government Siddha Medical college and
Hospital, Palayamkottai. Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9566852136 |
| Fax |
|
| Email |
eppoongodisri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A BALAMURUGAN |
| Designation |
Lecturer, Grade-II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal, Government Siddha Medical college and
Hospital, Palayamkottai. Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A BALAMURUGAN |
| Designation |
Lecturer, Grade-II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal, Government Siddha Medical college and
Hospital, Palayamkottai. Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital,Palayamkottai,
Tirunelveli 627002
|
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Government siddha medical college and hospital, Palayamkottai,
Tirunelveli, Tamil Nadu.627002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr E P Poongodi |
Government siddha medical College and hospital palayamkottai |
Room no 11
Department of noi naadal
Government siddha medical College and hospital palayamkottai 627002 Tirunelveli
Tirunelveli
TAMIL NADU |
9566852136
eppoongodisri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government siddha medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G629||Polyneuropathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Numbness present in both soles
Pricking sensation of the soles
Burning (or) sharp pain
Weakness of the body
Inability to bend (or) stretch the body |
|
| ExclusionCriteria |
| Details |
Below 30 years and above 70 years
Patients with any other serious illness |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Neerkuri & Neikuri for VADHA KARSANAM |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Naadi nadai for VADHA KARSANAM patients
To assess Manikadai nool in VADHA KARSANAM patients |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to document the differen neeekuri and t neikuri patterns and other siddha diagnostic methodology for patients with VADHA KARSANAM -Peripheral neuritis. |